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Comparison · NCT04742283-sae

Timolol Maleate Opthalmic Solution 0.5% BID vs DE-126 Opthalmic Solution 0.002% QD and Vehicle QD: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Timolol Maleate Opthalmic Solution 0.5% BID vs DE-126 Opthalmic Solution 0.002% QD and Vehicle QD: serious adverse events. Trial comparisons, record NCT04742283-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04742283-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.01880.00640.0537wilson
Risk in group 20.006210.00110.0343wilson
Risk difference, group 1 minus group 20.0125-0.01820.0478newcombe hybrid score
Risk ratio, group 1 over group 23.020.31728.7log
Odds ratio, group 1 over group 23.060.31529.7log
Number needed to harm, for one more participant with a serious adverse event on Timolol Maleate Opthalmic Solution 0.5% BID than on DE-126 Opthalmic Solution 0.002% QD and Vehicle QD79.8from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Timolol Maleate Opthalmic Solution 0.5% BIDTimolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)~Timolol Maleate Ophthalmic Solution 0.5% BID: Timolol Maleate Ophthalmic Solution BID (morning and evening)3160EG000
Group 2DE-126 Opthalmic Solution 0.002% QD and Vehicle QDDE-126 Ophthalmic Solution 0.002% is administered once daily (QD)~DE-126 Ophthalmic Solution 0.002% QD: DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning1161EG001

Harm

What it counts
Total, serious adverse events
Time frame
From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.

Source ClinicalTrials.gov

Trial

Title
Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
NCT number
NCT04742283
Phases
PHASE2
Conditions
Primary Open Angle Glaucoma, Ocular Hypertension
Interventions
DE-126 Ophthalmic Solution 0.002% QD, Timolol Maleate Ophthalmic Solution 0.5% BID
Lead sponsor
Santen Inc.
Results first posted
2023-01-26

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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